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AI Solutions: Certified and Market Ready

The list below includes solutions that have obtained at least one certification from any issuing authority.

This site attempts to document and display regulatory approvals. However, it is important to understand the differences in regulatory classifications and approvals from non-stringent in-country regulators as they reflect the depth of testing, post-market surveillance, as well as the ability to support end users.

DeepTek Inc.

Certification:

US FDA 510(k) clearance, Singapore HSA, Indian CDSCO + 5 others

Development:

On the Market

Intended Age Group

4+ Years

JF Healthcare

Certification:

China NMPA Class III

Development:

On the Market

Intended Age Group

15+ Years

Perceptra Company Limited

Certification:

Thai FDA Notification Certificate, HSA Singapore Authorization

Development:

On the Market

Intended Age Group

15+ Years

Shenzhen Smart Imaging Healthcare (ZYing) Co., Ltd

Certification:

China NMPA Class II
China NMPA Class III (Pending)

Development:

On the Market

Intended Age Group

15+

Delft Imaging Systems

Certification:

v7: CE Class IIb certified from 4 ages and above / v8: pending CE receipt

Development:

On the Market

Intended Age Group

4+Years

JLK

Certification:

CE-marked Class Ⅰ, Japan PMDA

Development:

On the Market

Intended Age Group

10+ Years

Qure AI

Certification:

CE Class IIb MDR (qXR v4.1), US FDA Breakthrough Device + 9 others

Development:

On the Market

Intended Age Group

3+ Years

VinBrain

Certification:

FDA 510(k) clearance, Vietnamese marketing clearance, ISO13485:2016

Development:

On the Market

Intended Age Group

3+ Years

Envision IT

Certification:

SAHPRA, US FDA 510(k) clearance , ISO 13485:2016

Development:

On the Market

Intended Age Group

6+ Years

Lunit

Certification:

CE MDR Class IIa, Korea MFDS

Development:

On the Market

Intended Age Group

4+ Years (CE), 14+ Years (Korea)

RadiSen

Certification:

CE-Marked Class IIa

Development:

On the Market

Intended Age Group

16+ Years

Vuno Inc

Certification:

CE MDD v1.1, CE MDR v1.2(2025.02), Korea MFDS v1.2, + 3 others

Development:

On the Market

Intended Age Group

19+ years

InferVision

Certification:

CE MDR class IIb

Development:

On the Market

Intended Age Group

16+ Years

Oxipit

Certification:

ChestEye: CE Class IIb, ChestLink: CE Class IIb

Development:

On the Market

Intended Age Group

18+ Years

Rayscape / Mindfully Technologies SRL

Certification:

CE Marked Class I, CE MDR class IIa (pending), ISO 13485

Development:

On the Market

Intended Age Group

16+ Years

AI Solutions: Certification Pending

Certification:

Pending

Development:

On the Market

Intended Age Group

0+ Years

Certification:

Korea MFDS (Pending)

Development:

On the Market

Intended Age Group

20+ Years

Certification:

Pending

Development:

On the Market

Intended Age Group

16+ Years

AI Solutions: Under Development

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Thai FDA (pending)

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

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